Cardium Reports on First Quarter 2009 Financial Results and Recent Developments
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SAN DIEGO, May 11 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex:
CXM) today reported its financial results for its first quarter ended March
31, 2009, and on recent developments and future outlook.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
Cardium made significant progress in the first quarter 2009 as the Company
continued to focus its efforts on the InnerCool Therapies and Tissue Repair
Company subsidiaries, both of which we believe are advancing toward important
asset value and monetization inflection points within Cardium's biomedical
opportunities portfolio. The Tissue Repair Company made important progress on
finalizing the completion of patient recruitment for its Phase 2b MATRIX
clinical trial of Excellarate(TM) for the potential treatment of diabetic
ulcers. At the same time, InnerCool continued forward with the successful
development of the UroCool(TM) pelvic cooling catheter system, which included
the submission for FDA 510(k) clearance to further enhance InnerCool's
portfolio of best-in-class temperature modulation therapy medical devices.
As initially reported in November 2008, Cardium instituted several important
strategic actions intended to focus and enhance its overall operating
structure and generate cost efficiencies. Based on these actions, cost
savings have begun to be reflected in the Company's operating results. In
particular, for the first quarter of 2009, Cardium's Loss from Operations was
reduced by almost 50% compared to the same period a year ago.
The first quarter 2009 financial results also include substantial non-cash
charges to adjust for the fair market value of certain common stock warrants
required beginning this quarter as a result of the adoption of Emerging Issues
Task Force EITF 07-05 entitled "Determining Whether an Instrument (or Embedded
Feature) is indexed to an Entity's Own Stock" by the Financial Accounting
Standards Board. In accordance with this new rule, stock warrants with
certain terms that were previously accounted for as equity are now required to
be recorded as a derivative liability with quarterly adjustments of their fair
value recorded on the income statement. These rule changes resulted in a $9.7
million "Change in Fair Value of Derivative Liabilities" reflecting the
substantially higher values associated with outstanding warrants to purchase
the Company's stock, since the price of Cardium's common stock increased by
about 125% during the first quarter.
Tissue Repair Company
On May 6, 2009, Cardium announced the completion of recruitment for the Phase
2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate
for the treatment of non-healing diabetic foot ulcers. The MATRIX Data and
Safety Monitoring Board has reviewed safety data collected from study
participants as of April 21, 2009 and reported that Excellarate appears to be
both safe and well tolerated, with no serious adverse events attributable to
the study product. Approximately 70% of the patients recruited in the MATRIX
study have already completed their initial evaluation period with respect to
key efficacy criteria, particularly the percentage of patients achieving
complete wound closure, the rate of wound closure and the reduction of wound
size at various time points. With confirmation of one or more medically
meaningful responses, Cardium and TRC would expect to meet with the U.S. Food
and Drug Administration (FDA) to review the complete safety and efficacy
database from this Phase 2b clinical study and their plans for initiating a
larger-scale Phase 3 pivotal study.
Cardium announced on May 7, 2009, that in parallel with the Phase 2b study and
in anticipation of a Phase 3 clinical study and future commercialization, the
Company's continuing process development activities have led to an important
breakthrough in product formulation that not only significantly simplifies the
use of Excellarate, but opens the door to additional potential applications of
the Excellarate technology in a number of other wound healing market
opportunities. The product formulation that was used in the Phase 2b study
required storage in a -70 degrees Celsius freezer and a two syringe mixing
process prior to treatment. The new product formulation is designed to be
maintained in a physician's office using a standard refrigerator (at a
temperature of about 4 degrees Celsius) and to have a shelf life of 12-18
months. It will also be formulated as an easy-to-use single syringe that is
pre-mixed and ready to be applied to patients' wounds.
The Company believes that with the completion of the Phase 2b MATRIX study,
the Tissue Repair Company will have reached a key valuation inflection point
within Cardium's investment portfolio and in concert with this, plans to
consider potential development and commercialization partnerships for
Excellarate with large pharmaceutical companies and companies focused on wound
healing. With continued clinical advancement, Excellarate offers the
potential to be commercially available in late 2011 or early 2012.
InnerCool Therapies
Cardium continues to build and enhance its InnerCool Therapies operating unit
with a specific focus on the development of a new class of targeted
organ-specific cooling applications, including its UroCool(TM) pelvic cooling
catheter system, which is designed to induce localized cooling during surgery
for prostate cancer. An application for FDA 510(k) clearance of the
UroCool(TM) system was submitted in the first quarter of 2009. Cardium
believes that InnerCool has reached a significant valuation inflection point
within Cardium's investment portfolio, and with the appropriate strategic
positioning, best-in-class products and a pipeline of innovative product
opportunities, Cardium intends to advance InnerCool's therapeutic cooling and
warming products into corresponding markets through the strategic sale of the
business to a large and diversified medical device company or through various
vertical partnering opportunities with established companies having existing
sales and marketing organizations but with a continuing need for innovative,
high-value content products. The Company believes this strategy is more
cost-effective than building InnerCool into a fully integrated manufacturing,
sales and marketing organization.
Financial Report
For the first quarter ended March 31, 2009, the Company reported a loss from
operations of $3.5 million, representing a 47% reduction from year ago levels,
as a result of various strategic actions initiated in the fourth quarter 2008.
The first quarter 2009 financial results also include substantial non-cash
charges to adjust for the fair market value of certain common stock warrants
required beginning this quarter as a result of the adoption of Emerging Issues
Task Force EITF 07-05, as noted above. Since the price of Cardium's common
stock increased by about 125% during the first quarter, this resulted in a
$9.7 million "Change in Fair Value of Derivative Liabilities," and resulted in
a reported net loss for the current period of $14.7 million, or $0.31 per
share, compared to a net loss of $6.7 million, or $0.16 per share for first
quarter 2008. Product revenue for the first quarter 2009 was $350,000,
compared to $534,000 in the same period in 2008 as InnerCool's direct sales
force was reduced consistent with the Company's new business strategy which is
focused on the marketing and sale of InnerCool products through corporate
accounts and web-based initiatives, and ultimately vertical partnering with
larger organizations having already established marketing and sales
organizations. Grant revenue for the first quarter 2009 was $18,000 compared
to $112,000 for the same quarter last year. Research and development costs
for the three months ended March 31, 2009 totaled $1.4 million and selling,
general and administrative expenses were $2.0 million, compared to $3.4
million and $3.4 million respectively for the same period last year. Cash and
cash equivalents as of March 31, 2009 were $1.4 million, compared to cash and
cash equivalents of $6.3 million as of March 31, 2008. Interest expense for
the three months ended March 31, 2009 was $1.6 million and includes $1.3
million representing the amortization of debt costs and warrant value issued
with the debt. During the first quarter 2009, the Company completed a secured
debt financing resulting in gross proceeds of approximately $3.5 million,
before placement agent fees and offering expenses and excluding any future
proceeds from the exercise of the warrants issued in the financing.
The Company continues to provide information in accordance with GAAP.
However, with the adoption of EITF 07-05 and its very substantial impact on
our overall reported net losses, varying substantially based on changes in the
underlying market value of Cardium's common stock, the Company believes it is
also helpful for investors to receive additional information relating more
specifically to the Company's operating results. Accordingly, the Company
additionally provides a pro forma income statement and pro forma balance sheet
which excludes the non-cash effects of EITF 07-05 on its financial results.
The Company presents this information to investors as an additional tool for
evaluating the Company's financial results in a manner that reflects ongoing
operations and facilitates comparisons with operating results from prior
periods. The presentation of this additional non-GAAP information is intended
to provide investors with additional incremental tools for their review of the
Company's results and is not meant to be considered in isolation or as a
substitute for net income information prepared and provided in accordance with
GAAP.
In late December 2008, Cardium received notification from the staff of its
current listing exchange indicating that the Company was considered to be
noncompliant with certain listing requirements of the NYSE Amex. On January
23, 2009, the Company submitted a proposed plan outlining how it could
establish compliance with the requirements of section 1003(a)(iv) by March 23,
2009, and establish compliance with all sections, including section
1003(a)(i), by June 23, 2010. Cardium received notification in late February
that its plan had been accepted by the exchange, but remains subject to
continuing review by the exchange with respect to the carrying out of its plan
and the achievement and maintenance of overall compliance. On April 9, 2009,
the exchange notified Cardium that it had extended the time for compliance
with the requirements of section 1003(a)(iv) from March 23, 2009 to June 27,
2009; and that the Company would also need to regain compliance with section
1003(a)(ii) of the exchange's company guide regarding maintenance of
stockholder's equity of at least $4 million, which it would need to do by June
23, 2010.
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc. and
the Tissue Repair Company, are medical technology companies primarily focused
on the development, manufacture and sale of innovative therapeutic products
and devices for cardiovascular, ischemic and related indications.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medical
technology company in the emerging field of temperature modulation therapy to
rapidly and controllably cool the body in order to reduce cell death and
damage following acute ischemic events such as cardiac arrest or stroke, and
to potentially lessen or prevent associated injuries such as adverse
neurological outcomes. For more information about Cardium's InnerCool
subsidiary and patient temperature modulation, including InnerCool's new
RapidBlue(TM) System, which just received FDA clearance, and its CoolBlue(TM)
System, please visit www.innercool.com.
Cardium also has two biologic candidates in clinical development. Cardium's
Tissue Repair Company subsidiary (TRC) is focused on the development of growth
factor therapeutics for the treatment of severe chronic diabetic wounds.
TRC's lead product candidate, Excellarate(TM), is a DNA-activated collagen gel
for topical treatment formulated with an adenovector delivery carrier encoding
human platelet-derived growth factor-BB (PDGF-BB). Excellarate(TM) is
initially being developed to be administered once or twice for the potential
treatment of non-healing diabetic foot ulcers. Other potential applications
for TRC's Gene Activated Matrix(TM) (GAM) technology include therapeutic
angiogenesis (cardiovascular ischemia, peripheral arterial disease) and
orthopedic products, including hard tissue (bone) and soft tissue (ligament,
tendon, cartilage) repair. For more information about Cardium's Tissue Repair
Company subsidiary, please visit www.t-r-co.com.
Cardium's Generx product candidate (alferminogene tadenovec, Ad5FGF-4) is a
DNA-based growth factor therapeutic designed for use by interventional
cardiologists as a potential one-time treatment to promote and stimulate the
growth of collateral circulation in the hearts of patients with ischemic
conditions such as recurrent angina. For more information about Cardium
Therapeutics and its businesses, products and therapeutic candidates, please
visit www.cardiumthx.com or view its most recent annual report on Form 10-K
and other reports as filed with the Securities and Exchange Commission and
available on the company's website.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press
release are forward looking and reflect numerous assumptions and involve a
variety of risks and uncertainties, many of which are beyond our control and
may cause actual results to differ materially from stated expectations. For
example, there can be no assurance that results or trends observed in
pre-clinical studies will be reproduced in subsequent studies, that human
clinical trials can be conducted and completed in an efficient and successful
manner, that partnering, asset monetization or other strategic development
opportunities can be successfully achieved and that such opportunities will
effectively and efficiently advance commercialization of our products, that we
can raise sufficient capital from partnering, monetization or other
fundraising transactions to maintain our stock exchange listing or adequately
fund ongoing operations, that product modifications or launches will be
successful or that the resulting products will be favorably received in the
marketplace, that results or trends observed in one clinical study will be
reproduced in subsequent studies, that our products or product candidates will
prove to be sufficiently safe and effective, that necessary regulatory
approvals will be obtained, or that our products or product candidates will
not be unfavorably compared to competitive products that may be regarded as
safer, more effective, easier to use or less expensive. Actual results may
also differ substantially from those described in or contemplated by this
press release due to risks and uncertainties that exist in our operations and
business environment, including, without limitation, risks and uncertainties
that are inherent in the development of complex biologics and therapeutic
hypothermia devices and in the conduct of human clinical trials, including the
timing, costs and outcomes of such trials, our ability to obtain necessary
funding, regulatory approvals and expected qualifications, our dependence upon
proprietary technology, our history of operating losses and accumulated
deficits, our reliance on collaborative relationships and critical personnel,
and current and future competition, as well as other risks described from time
to time in filings we make with the Securities and Exchange Commission. We
undertake no obligation to release publicly the results of any revisions to
these forward-looking statements to reflect events or circumstances arising
after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved. For Terms of
Use Privacy Policy, please visit www.cardiumthx.com. Cardium Therapeutics(TM)
and Generx(R) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM),
Gene Activated Matrix(TM), GAM(TM), and Excellarate(TM) are trademarks of
Tissue Repair Company.
InnerCool Therapies(R), InnerCool(R), RapidBlue(TM) and CoolBlue(TM) are
trademarks of InnerCool Therapies, Inc.
- Continued -
Cardium Therapeutics, Inc.
Selected Condensed Consolidated Results of Operations
Three Months Ended March 31,
(Unaudited)
EITF 07-05
2009 Actual Effect* Pro forma 2009* 2008
Revenues $368,413 - $368,413 $646,002
Cost of goods
sold (206,594) - (206,594) (370,696)
Gross profit 161,819 - 161,819 275,306
Research and
development 1,426,728 - 1,426,728 3,372,480
Selling,
general and
administrative 2,025,035 - 2,025,035 3,385,566
Amortization -
Intangibles 197,414 - 197,414 197,414
Loss from
operations (3,487,358) - (3,487,358) (6,680,154)
Interest income
(expense), net (1,592,890) - (1,592,890) (53,974)
Change in fair
value of
derivative
liabilities (9,656,629) 9,656,629 - -
Net loss $(14,736,877) 9,656,629 $(5,080,248) $(6,734,128)
Net loss per
common share
- basic and
diluted $(0.31) $(0.11) $(0.16)
Weighted
average common
shares
outstanding -
basic and
diluted 46,930,439 46,930,439 40,709,247
Selected Condensed Consolidated Balance Sheet Data
March 31, Pro forma December 31,
2009 EITF 07-05 March 31, 2008
(Unaudited) Effect* 2009* (Audited)
Cash and cash
equivalents $1,426,967 - $1,426,967 $1,102,894
Accounts receivable,
net 278,879 - 278,879 296,116
Inventories, net 1,917,769 - 1,917,769 2,000,385
Prepaid expenses
and other
current assets 744,464 - 744,464 642,246
Property and equipment,
net 1,525,297 - 1,525,297 1,706,065
Patented technology
and intangibles,
net 3,779,260 - 3,779,260 3,976,674
Other long-term assets 620,041 - 620,041 572,541
Total assets $10,292,677 - $10,292,677 $10,296,921
Accounts payable
and accrued
liabilities $6,574,030 - $6,574,030 $6,819,586
Short-term debt 7,187,038 - 7,187,038 4,036,776
Derivative
liabilities 14,860,984 (14,860,984) - -
Long-term
liabilities 197,789 - 197,789 195,315
Stockholder's
deficiency (18,527,164) 14,860,984 (3,666,180) (754,756)
Total liabilities
and stockholder's
deficiency $10,292,677 - $10,292,677 $10,296,921
* Note: additional pro forma information is included to reflect the
effects of non-cash charges associated with the treatment of the value of
certain derivative securities under newly-adopted EITF 07-05, which
effects can vary substantially each quarter along with changes to the
price of the underlying common stock during the quarter. The Company
presents this information to investors as an additional tool for
evaluating the Company's financial results in a manner that reflects
ongoing operations and facilitates comparisons with operating results from
prior periods. The presentation of this additional non-GAAP information
is intended to provide investors with additional incremental tools for
their review of the Company's results and is not meant to be considered in
isolation or as a substitute for the actual net income information
prepared and provided in accordance with GAAP.
SOURCE Cardium Therapeutics
Bonnie Ortega, Director, Investor/Public Relations of Cardium Therapeutics,
Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
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